Pilocarpine and Brimonidine in Patients With Monofocal Lenses

Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03825081

Enrollment

Registered

2019-01-31

Start date

2019-01-21

Completion date

2019-12-31

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia, Pseudophakia

Brief summary

The current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.

Detailed description

This research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. Thirty-three subjects will take part in this research study. Baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear Infirmary (MEEI).

Interventions

DRUGBrimonidine, pilocarpine

1 drop of pilocarpine (0.5%) 1 drop of brimonidine (0.2%)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. Men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who need only +/- 2.5 D correction for reading. Given the age group selected only post menopausal women will be evaluated.

Exclusion criteria

* Individuals meeting any of the

Design outcomes

Primary

Measure	Time frame	Description
Change in visual acuity after administration of pilocarpine and brimonidine	baseline; hour 1	The primary aim of our study is to determine if the combination of pilocarpine and brimonidine improves near visual acuity in pseudophakic subjects 1 hour following drop placement, compared to baseline.

Secondary

Measure	Time frame	Description
Change in near and distance visual acuity	baseline; hours 1; 3; and 6	Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.

Countries

United States

Contacts

Primary ContactMatthew Gardiner, MD

Matthew_Gardiner@meei.harvard.edu617-573-3202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026